The agency was originally scheduled to announce its call on Sunday. The company said it hadn’t flagged any issues with the ...

The FDA needs a few more weeks to decide the fate of Moderna's RSV vaccine, the company announced. A decision is now slated ...

The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.

Moderna shares fell in intraday trading Friday as it said the FDA has pushed back its RSV vaccine approval decision until the ...

Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's ...

The U.S. drug regulator has pushed back its decision on Moderna's respiratory syncytial virus (RSV) vaccine due to ...

Moderna on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for respiratory syncytial virus due to “administrative constraints ...

The FDA is working to conclude its review by the end of May 2024. The Food and Drug Administration (FDA) has informed Moderna that its review of the Biologics License Application (BLA) for mRNA-1345, ...

The FDA has not informed Moderna of any issues related to the vaccine's safety, efficacy or quality that would prevent its ...

(Reuters) -The U.S. drug regulator has pushed back its decision on Moderna's respiratory syncytial virus (RSV) vaccine due to "administrative constraints" and will complete the review by the end ...